VAN-TEC BLADDER EVACUATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEPUY ATTUNE TOTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER

FDA 510(k)

FDA Class 2 ·Dental

CXI SUPPORT CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

URISYS 2400 URINE TEST STRIP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MYLABSEVEN, MYLABALPHA

FDA 510(k)

FDA Class 2 ·Radiology

ANATOMIC MODULAR KNEE (AMK) SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Zimmer Persona Personalized Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF

FDA 510(k)

FDA Class 2 ·Orthopedic

Arcos One-piece Femoral Revision System

FDA 510(k)

FDA Class 2 ·Orthopedic

Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

FDA Pre-Market Approval

FDA Class 2 ·PRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLER

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.